MAUDE Adverse Event Report: ABBOTT SRL ALINIQ AMS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed that the noytr calculation rule is not working for the hematology advia platform.The noytr rule is calculated from neutrophil and ig cells.Since the advia platform does not measure ig cells, the noytr rule does not work for the advia platform.However, the noytr rule works with the alinity hq processing module.The customer initial run cbc on alinity hq processing module.When the customer has a delta check or needs to repeat a complete blood count (cbc), they repeat it on the advia platform.At that time, the cbc+diff is reported from advia, and ig results come from alinity hq.In that situation, the total differential count is higher than 100%, which is incorrect.The differential count should not exceed 100%.For this reason, the customer is requesting to remove the advia hematology platform from that rule family in ams.The customer did not provide any information about missed or delayed treatments.There were no discrepant patient results provided by the customer.No impact to patient management reported by the customer.
Additional Manufacturer Narrative
The complaint investigation on the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.The aliniq ams technical group investigated the noytr rule, that calculates the neutrophil count using neutrophil and immature granulocyte (ig) cells.The investigation confirmed the issue arose because the same calculation rule was incorrectly applied to two different instruments with different test parameters.No deficiency of the middleware was identified.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams middleware, version 3.01, was identified.
Event or Problem Description
The customer observed that the noytr calculation rule is not working for the hematology advia platform.The noytr rule is calculated from neutrophil and ig cells.Since the advia platform does not measure ig cells, the noytr rule does not work for the advia platform.However, the noytr rule works with the alinity hq processing module.The customer initial run cbc on alinity hq processing module.When the customer has a delta check or needs to repeat a complete blood count (cbc), they repeat it on the advia platform.At that time, the cbc+diff is reported from advia, and ig results come from alinity hq.In that situation, the total differential count is higher than 100%, which is incorrect.The differential count should not exceed 100%.For this reason, the customer is requesting to remove the advia hematology platform from that rule family in ams.The customer did not provide any information about missed or delayed treatments.There were no discrepant patient results provided by the customer.No impact to patient management reported by the customer.

• Brand Name: ALINIQ AMS
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer (Section G): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21766778
• Report Number: 3004032053-2025-00009
• Device Sequence Number: 8591276
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169(10)3.01
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown